COMPARATIVE EFFECT OF HOLD-RELAX PERIPHERAL NEUROMUSCULAR FACILITATION TECHNIQUE WITH AND WITHOUT CONVENTIONAL PHYSICAL THERAPY ON KNEE TORQUE AND MOTOR FUNCTION IN CHILDREN WITH SPASTIC CEREBRAL PALSY
To compare the effect of conventional physiotherapy with and without hold- relax PNF Exercises on knee torque and motor function in children with spastic cerebral palsy.
Design
single-blind randomized controlled trial
Settings and conduct
Ambulatory patients of cerebral palsy having GMFC of 1 and 2 in the rehabilitation department of Rehab Care School for Special Children Lahore fulfill the inclusion criteria of the study.
The assessor was not aware of the treatment given to either group.
Participants/Inclusion and exclusion criteria
8-16 years old cognitive children with spastic cerebral palsy having Knee flexor and extensors grade 3 and above according to manual muscle testing.
Intervention groups
hold- relax peripheral neuromuscular facilitation technique along with conventional physical therapy. The exercise program included:
o Dynamic stretching utilizing the principles of hold relax peripheral neuromuscular facilitation. Keeping the knee straight, the patient was asked to lift the leg for 7 seconds while the therapist held the leg from moving. The muscles were relaxed for 2 seconds while holding the new position. The process was repeated five times and the whole set was done 66 times with a 2-minute rest between each set.
o Conventional static stretching was done at the start of the protocol for 5 minutes.
Main outcome variables
• knee torque.
• motor function
• functional capability
• spasticity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240530061952N1
Registration date:2024-06-15, 1403/03/26
Registration timing:retrospective
Last update:2024-06-15, 1403/03/26
Update count:0
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
Azka Zulfiqar
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 308 0529889
Email address
azka286@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-05, 1402/09/14
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
2023-12-15, 1402/09/24
Actual recruitment end date
2024-01-12, 1402/10/22
Trial completion date
2024-04-18, 1403/01/30
Scientific title
COMPARATIVE EFFECT OF HOLD-RELAX PERIPHERAL NEUROMUSCULAR FACILITATION TECHNIQUE WITH AND WITHOUT CONVENTIONAL PHYSICAL THERAPY ON KNEE TORQUE AND MOTOR FUNCTION IN CHILDREN WITH SPASTIC CEREBRAL PALSY
Public title
Effect of hold relax technique on knee movement of children with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 8-16 years
Ambulatory patient
Normal vision, as well as hearing, and the ability to follow instructions
Knee flexor and extensors grade 3 and above according to manual muscle testing
Exclusion criteria:
The patient was unable to respond physically or mentally
Subjects with Gross Motor Functional Classification levels 4 and 5
Fixed contractures or deformities of the spine or extremities
History of surgical interference of the spine or lower extremities within 1 year
Age
From 8 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
53
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
participants were randomly allocated to different groups using the sealed enveloped method
Non-probability, purposive sampling.
A single-blind randomized controlled trial was performed. The assessor was not aware of the treatment given to either group
Blinding (investigator's opinion)
Single blinded
Blinding description
A single-blind randomized controlled trial was performed. The outcome assessor (senior physiotherapist)was not aware of the treatment given to either group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee (REC) Faculty of Allied Health Sciences The University of Lahore
Street address
University of lahore Defence Road Campus, 1-Km, DefenceRoad, 10-Km, LahoreRoad, Off Bhobatian Chowk, Lahore.
City
Lahore
Postal code
54792
Approval date
2023-09-28, 1402/07/06
Ethics committee reference number
REC-UOL-537-09-2023
Health conditions studied
1
Description of health condition studied
Cerebral Palsy
ICD-10 code
G80.9
ICD-10 code description
Cerebral palsy, unspecified
Primary outcomes
1
Description
Knee torque
Timepoint
Baseline, 6,12 weeks
Method of measurement
Dynamometer
2
Description
Motor function
Timepoint
Before intervention ,6,12 weeks
Method of measurement
Gross motor function scale
3
Description
Functional capability
Timepoint
Before intervention, 6, 12 weeks
Method of measurement
Sit and reach test
4
Description
Spasticity
Timepoint
Before intervention, 6, 12 weeks
Method of measurement
Modified Tardieu Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The children in the experimental group received a hold-relax peripheral neuromuscular facilitation technique along with conventional physical therapy. The exercise program included: Dynamic stretching utilizing the principles of hold relax peripheral neuromuscular facilitation. Keeping the knee straight, the patient was asked to lift the leg for 7 seconds while the therapist held the leg from moving. The muscles were relaxed for 2 seconds while holding the new position. The process was repeated five times and the whole set was done 66 times with a 2 minute rest between each set. Conventional static stretching was done at the start of the protocol for 5 minutes.
Category
Rehabilitation
2
Description
Control group: All children in this group underwent an especially designed Conventional Physical Therapy Program for 40 minutes, 3 times per week for 12 successive weeks. The exercise program included the following:Static Stretching at the knee, ankle, and hip. Knee isometrics for knee strengthening.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehab Care School for special children
Full name of responsible person
Dr. Khushbakht
Street address
176, block Q1, Wapda Town, Phase 2, Lahore
City
Lahore
Postal code
54770
Phone
+92 333 1048076
Email
admin@rehabcare.pk
Web page address
https://rehabcare.com.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Umair Ahmed
Street address
University of Lahore, Defence road Campus,1 km off Bhoobtian road, Lahore
City
Lahore
Postal code
53700
Phone
+92 42 35322501
Email
info@uol.edu.pk
Web page address
https://uol.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Azka Zulfiqar
Position
MS- PT student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
120- D Muhafiz Town Multan Road Lahore
City
Lahore
Province
Punjab
Postal code
53700
Phone
+92 308 0529889
Email
azka286@gmail.com
Web page address
https://uol.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Azka Zulfiqar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
120- D Muhafiz Town Multan road Lahore
City
Lahore
Province
Punjab
Postal code
53700
Phone
+92 42 35322501
Email
azka286@gmail.com
Web page address
https://uol.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Azka Zulfiqar
Position
MS- PT student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
120-D Muhafiz Town Multan Road Lahore
City
Lahore
Province
Punjab
Postal code
53700
Phone
+92 308 0529889
Email
azka286@gmail.com
Web page address
https://uol.edu.pk/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Collection data set for knee torque CP
When the data will become available and for how long
Data can be provided within 6 months of publication
To whom data/document is available
Supporting documents can be provided on request to academic institutions
Under which criteria data/document could be used
Academic institutions can use the data for further research
From where data/document is obtainable
Documents are available on request on azka286@gmail.com
What processes are involved for a request to access data/document
Documents are available on request on azka286@gmail.com
Comments
For additional information contact on azka286@gmail.com